TOPIC I

Trial details

Multicentre randomised trial comparing the efficacy and toxicity of pre-operative chemotherapy in women with histologically proven 3cm3 invasive early breast cancer. 426 patients from 18 centres were randomised between October 1993 and February 1999 to receive either 5-fluorouracil (5-FU) by daily 24 hour continuous infusion via a Hickman line for 18 weeks with epirubicin and cisplatin given as intravenous bolus injections, or conventional bolus doxorubicin (AC) and cyclophosphamide. Both schedules were repeated 3 weekly for 6 courses and oral tamoxifen was prescribed as appropriate. The need for conservative surgery with axillary resection or mastectomy and/or radiotherapy was reviewed post-chemotherapy based on clinical tumour size after treatment. Publication concluded that preoperative continuous infusional 5FU based chemotherapy is no more active than conventional AC for early breast cancer with a median 5 year follow-up. Long-term follow-up needs to be reviewed to assess whether differences in clinical response can predict for long-term outcome.

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